BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    JBAIDS PLAGUE DETECTION KIT

    K Number: K131729 · Decision Jul 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    5
    Review Days
    49

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    Basic Information

    Device Name
    JBAIDS PLAGUE DETECTION KIT
    K Number
    K131729
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biofire Diagnostics, Inc.
    Date Received
    June 12, 2013
    Decision Date
    July 31, 2013
    Product Code
    OIH
    Advisory Committee
    Unknown
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OIH Yersinia Spp. Reagents

    Other Clearances by Biofire Diagnostics, Inc.

    K Number Device Name
    K131930 JBAIDS ANTHRAX DETECTION KIT
    K131936 JBAIDS TULAREMIA DETECTION KIT
    K130914 FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL
    K123620 FILMARRAY RESPIRATORY PANEL (RP)